Thermo Fisher QS1 (ThermoFisher QuantStudio v1.5 or higher)
Qiagen Rotor-Gene Q (Qiagen Rotor-Gene Q software 2.3.5 or higher)
Applied Biosystems ABI 7500 Fast Real Time PCR Dx (Applied Biosystems ABI 7500 Software v2.3 or higher OR Applied Biosystems 7500 System SDS v1.4 Software 1 CFR Part 11 Module or higher)
DNA Technologie DTPrime5 (DNA Technologies RealTime PCR v7.9 or higher)
Analytik Jena qTower 3G (Analytik Jena qPCRsoft 4.0 or higher)
Compatible with any qPCR Machine
FDA EUA approved
CE mark approved
Sure Bio-Tech API Covid-Rapid is Registered by the FDA. Covid-Rapid is Available for Sale to Medical Providers Only. Not for home use.
Updated US FDA guidance issued on March 16, 2020 allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. This test is not intended for home use and must be used under the prescription of a licensed professional. All positive tests should be reported to your local health department. This will help local and state officials understand the breadth and depth of the epidemic and may help guide public policy decision making. This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been recently in contact with the virus or are high risk. Testing with a molecular diagnostic should be considered to rule out infection in these individuals. Patients should care for themselves and those around them by continuing to quarantine for another few days. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.